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EP0470308A1 - Correction chirurgicale de l'incontinence urinaire féminine causée par le stress et jeu d'instruments - Google Patents

Correction chirurgicale de l'incontinence urinaire féminine causée par le stress et jeu d'instruments Download PDF

Info

Publication number
EP0470308A1
EP0470308A1 EP90308730A EP90308730A EP0470308A1 EP 0470308 A1 EP0470308 A1 EP 0470308A1 EP 90308730 A EP90308730 A EP 90308730A EP 90308730 A EP90308730 A EP 90308730A EP 0470308 A1 EP0470308 A1 EP 0470308A1
Authority
EP
European Patent Office
Prior art keywords
cannula
pair
needle
implants
kit according
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP90308730A
Other languages
German (de)
English (en)
Inventor
Claude 5460 Route Marie Victorin Lemay
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
R Laborie Medical Corp
Original Assignee
R Laborie Medical Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by R Laborie Medical Corp filed Critical R Laborie Medical Corp
Publication of EP0470308A1 publication Critical patent/EP0470308A1/fr
Withdrawn legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0031—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
    • A61F2/0036—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable
    • A61F2/0045—Support slings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/062—Needle manipulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A61B50/33—Trays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00805—Treatment of female stress urinary incontinence
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S128/00—Surgery
    • Y10S128/25—Artificial sphincters and devices for controlling urinary incontinence

Definitions

  • the present invention is directed to a method for the surgical correction of female urinary stress incontinence and a kit therefor. More particularly, the present invention is directed to a surgical technique for urethropexy and a kit containing materials to effectuate the technique.
  • kits for use in the surgical correction of female urinary stress incontinence comprising:
  • the kit comprises:
  • the present invention also provides a saddle for supporting a neck portion of the female urethra comprising:
  • the present invention provides a surgical corrective technique for all human female stress urinary incontinence including fibrous perineal tissue due to irradiation by surgery or trauma.
  • the technique is particularly suitable for patients suffering from coronary artery disability and chronic obstructive pulmonary illness, as well as elderly patients and patients suffering from Alzheimer's disease, etc.
  • the only contra-indication is for patients whose vaginal tissue cannot support abdominal pressure. Bladder atony, in itself, is a contra-indication.
  • a proper diagnosis also depends upon an adequate physical examination.
  • the examination must reveal the degree of cysto-urethrocele as well as the mobility of the perineal and urethral tissue structures.
  • a cystoscope is introduced into the urethra, and residual urine is recorded and the bladder is then slowly distended, without pressure, while the urethra and bladder are visually inspected.
  • the length of the urethra is recorded at the start of the inspection and when the bladder is full, but not distended.
  • the cystoscope is removed and the patient is asked to cough several times. Stress incontinence is clearly noted when urine exits the urethral meatus simultaneously with the coughing. A delay of a few seconds in the incontinence indicates a hyporeflexic or unstable bladder.
  • the Bonney Test (Marshall) is performed to confirm the continence and to indicate the necessary degree of urethropexy.
  • a urine culture is taken and, if the urine culture is negative, no antibiotics are necessary.
  • a preoperative medication e.g., Diazepam (5 gm) is administered to alleviate anxiety, with the patient in the lithotomy position, knees slightly withdrawn.
  • a catheter e.g., a No. 18 Foley catheter
  • a local anesthetic e.g., 4 cc of Xylocaine 2%
  • a local anesthetic e.g., 4 cc of Xylocaine 2%
  • a small retractor allows visualization of the urethro-vesical junction region in the vagina, and a local anesthetic, e.g., about 2 cc of Xylocaine 2%, is injected at this point.
  • the intervention comprises the placement of two implants which will anchor sutures holding the urethro-vesical juncture at a desired angle.
  • the implant generally indicated at 1, comprises a head portion 3 and a suture portion 5.
  • the head portion 3 is adapted to rest on the pubic bone (symphysis pubis) and is preferably of a substantially figure eight configuration having a central cross bar 7, when viewed from above.
  • the head portion 3 may be formed of any medically acceptable non-biodegradable implant material, preferably a metallic material such as the surgical titanium alloy having the composition given in Table 1. Such a titanium alloy has a tensile strength of about 130,000 psi and an elongation of about 120,000 psi.
  • the head portion 3 may be encased in a layer of a biologically acceptable coating material 9 (shown in phantom lines), e.g., medical grade silicone rubber.
  • the suture portion 5 comprises a surgical suture acceptable, substantially non-biodegradable thread having a first end 11, a second end 13 and a central portion 15.
  • the central portion 15 is wrapped about the central cross bar 7 with the first end 11 and the second end 13 disposed on the same side of the head portion 3.
  • the thread used for the suture portion may be any conventionally available, non-biodegradable suture material, e.g., 0.5 mm diameter Surgilen (Blue) or Prolene.
  • the first end 11 and the second end 13 will extend 25-40 cms, preferably 30-35 cms, from the head portion 3.
  • the head portion 3 typically, has a length (A) of about 10-15 mm, preferably, about 12 mm; a width (C) of about 4-5 mm; and a height (B) of about 3-4 mm.
  • the intervention generally requires the utilization of at least one needle, preferably a pair of needles.
  • the needles as illustrated in Fig. 2, each comprise a cannula 17 and a trocar 19.
  • the trocar is removably, slidingly, disposable with the cannula.
  • Each of the needles is bendable to a desired degree of curvature.
  • the needles are generally supplied with a radius of curvature of about 100-105 mm, preferably about 102 mm, but may be bent to conform to the internal curve of the patients vagina.
  • the needles are generally about 150 mm long with the cannula having an outside diameter of about 0.80 to 0.95 mm and with the trocar having an outside diameter of about 0.60 mm, e.g., a 19.5 gauge needle.
  • the intervention generally proceeds, as follows:
  • the ends of the respective threads may be threaded through a reinforcing element to provide additional support.
  • a reinforcing element may be as simple as a small strip of biologically acceptable cloth, e.g., medical grade Dacron (polyethylene terephthalate polyester).
  • a saddle as illustrated in Figs. 3A, 3B and 3C may be used to hold the neck of the urethra, following its contour, while providing increased rigidity.
  • the saddle generally indicated at 21, comprises a substantially rectangular, planar base 23 having an upper surface 25, a lower surface 27 and four corners.
  • a pair of arms 37, 39 protrude upwardly and outwardly from a central portion 41 of the upper surface 25 of the base 23.
  • the arms are integrally formed with the base, from medical grade silicone rubber, and form a substantially V-shaped notch (best seen in Fig.
  • a reinforcing element 43 is attached to the lower surface 27 of the base 23 and extends coextensively with the base 23.
  • a series of bores 45, 47, 49, 51, having a diameter of about 0.7 mm, are provided in respective corners 29, 31, 33, 35 of the saddle 21 so as to receive the various ends of the threads from the implants therethrough. The ends of the threads may be tied together to support the saddle, which in turn supports the neck portion of the urethra at a desired angle.
  • the reinforcing element 43 which may be formed of medical grade polyester, e.g., Dacron (polyethylene terephthalate), prevents the threads from cutting the silicone rubber forming the base 23.
  • the saddle 21, typically, has a length (D) of about 15 mm, although it may be supplied in different lengths so as to better conform to normally expected physiological differences between patients, e.g., lengths of 18.5 mm and 22 mm could also be supplied; a width (F) of about 20 mm; and a height (E) of about 10 mm.
  • the reinforcing element 43 has a height (G) of about 1 mm.
  • the Foley catheter Prior to the above-noted steps (20), (21) and (22), the Foley catheter is removed and a cystoscope is introduced to ensure that suture material is not present in the bladder, and, if necessary, to ensure that the bladder neck is not closed by traction on the implants.
  • the bladder is left full and the instrument removed.
  • the implants may be buried under the skin, using hemostatic forceps, over the symphysis pubis while making sure not to create an umbilicus.
  • the sutures By asking the patient to cough, to demonstrate incontinence, the sutures are then tied by lifting the urethro-vesical junction to a desired angular position. Again, the patient is asked to cough and continence is immediately observed.
  • the sutures, parallel to one another, are now tied up at the same position.
  • the patient can be mobile, drink and eat right after her operation.
  • An analgesic may be needed for several hours post-operatively. Antibiotic therapy is not indicated unless the urine culture was positive. Normal voiding may start as early as the next morning, after the cystostomy is closed or the catheter removed. In 85% of the cases the cystostomy is closed or the catheter removed on the third day (although in some cases it has been as long as 22 days). Patients are examined at 3 days, 2 months, 6 months and 1 year after the procedure.
  • the present invention also provides a kit, illustrated in Fig. 2 to aid in effectuation of the surgical procedure disclosed above.
  • the kit provides a pair of needles comprising two cannula 17 and two trocars 19 and a pair of implants 1.
  • the needles and implants are packaged on a tray 53 comprising a planar central portion 55 surrounded by an upstanding circumferential wall 57 and a lip 59 extending outwardly from the top of the wall 57.
  • a plurality of raised portions 61 are formed on central portion 55 and define a plurality of gaps 63 therebetween.
  • a pair of hollow cylinders 65 supportingly receive respective suture portions 5 of the pair of implants 1 therein.
  • the tray may be formed of any substantially rigid material capable of withstanding conventional sterilization techniques without failure, e.g., a thermoset resin.
  • a cover (not shown), such as a clear film, may be bonded to the lip 59 of the tray, or preferably the tray may be packaged in a wrapping, to allow sterilization of the tray and its contents.
  • the above described transfixation technique is totally unique in that it uses implants on the symphysis pubis and in that it is performed under only local anesthesia, as compared to existing procedures. It requires only a short hospital stay and it is equally applicable to the young and athletically inclined person and the high-risk surgical patient. If necessary, it is also a repeatable technique.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Urology & Nephrology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Surgical Instruments (AREA)
  • Prostheses (AREA)
EP90308730A 1989-02-24 1990-08-08 Correction chirurgicale de l'incontinence urinaire féminine causée par le stress et jeu d'instruments Withdrawn EP0470308A1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US07/315,279 US5013292A (en) 1989-02-24 1989-02-24 Surgical correction of female urinary stress incontinence and kit therefor

Publications (1)

Publication Number Publication Date
EP0470308A1 true EP0470308A1 (fr) 1992-02-12

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP90308730A Withdrawn EP0470308A1 (fr) 1989-02-24 1990-08-08 Correction chirurgicale de l'incontinence urinaire féminine causée par le stress et jeu d'instruments

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US (1) US5013292A (fr)
EP (1) EP0470308A1 (fr)

Cited By (62)

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EP0639355A1 (fr) * 1993-08-21 1995-02-22 RULL, Johann, Dr. med. Prothèse pour remédier à l'incontinence urinaire chez la femme
WO2002062237A1 (fr) * 2001-01-23 2002-08-15 American Medical Systems, Inc. Systeme de mise en place d'une fronde chirurgicale
US6592515B2 (en) 2000-09-07 2003-07-15 Ams Research Corporation Implantable article and method
US6641525B2 (en) 2001-01-23 2003-11-04 Ams Research Corporation Sling assembly with secure and convenient attachment
US6648921B2 (en) 2001-10-03 2003-11-18 Ams Research Corporation Implantable article
US6652450B2 (en) 2001-01-23 2003-11-25 American Medical Systems, Inc. Implantable article and method for treating urinary incontinence using means for repositioning the implantable article
US6691711B2 (en) 1998-04-24 2004-02-17 Ams Research Corporation Method for correction of urinary and gynecological pathologies including treatment of incontinence
WO2005048878A1 (fr) * 2003-11-12 2005-06-02 Ethicon, Inc. Ensemble de conditionnement pour instruments chirurgicaux
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US9084664B2 (en) 2006-05-19 2015-07-21 Ams Research Corporation Method and articles for treatment of stress urinary incontinence
US9089393B2 (en) 2011-03-28 2015-07-28 Ams Research Corporation Implants, tools, and methods for treatment of pelvic conditions
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US9351723B2 (en) 2011-06-30 2016-05-31 Astora Women's Health, Llc Implants, tools, and methods for treatments of pelvic conditions
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US9468512B2 (en) 2010-10-06 2016-10-18 Astora Women's Health, Llc Implants with absorbable and non-absorbable features for the treatment of female pelvic conditions
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